FDA Inspection 1095779 — Seth M.Pollack, M.D.
The FDA completed an inspection of Seth M.Pollack, M.D. on June 27, 2019 in Seattle, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 27, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Seattle, WA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 7209 | 21 CFR 50.25(a)(1) | Procedures, identification of those which were experimental |
| 7227 | 21 CFR 50.27(a) | Consent form not approved/signed/dated |
| 7388 | 21 CFR 50.25(a)(2) | Reasonably foreseeable risks or discomforts |
| 7517 | 21 CFR 312.66 | Initial and continuing review |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |